On November 4, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has received the clinical hold letter from the U.S. Food and Drug Administration (FDA) with respect to its Investigational New Drug Application (IND) (Press release, PharmaCyte Biotech, NOV 4, 2020, View Source [SID1234569866]). The company had previously announced on October 2, 2020 that it has received notification from the FDA that its IND had been placed on clinical hold.
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In order to lift the clinical hold, the FDA has informed the company that it needs to conduct several additional preclinical studies. The FDA also requested additional information regarding several topics, including data, manufacturing information and product release specifications.
In addition, the FDA requested that several items not related to the clinical hold be addressed via submission of an IND amendment. Specifically, the FDA requested that the company perform qualification studies for the drug substance filling step to ensure that the product remains sterile and stable during the filling process. The FDA also requested additional information, discussion and clarification on several other topics.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "Our team of experts is developing action plans to address the clinical hold letter. Since the FDA’s letter included a lengthy list of items and several preclinical studies, at this time it’s impossible to say when the company will be in a position to submit a complete response to the FDA. One big reason for the uncertainty is because some of the preclinical studies will be performed by outside third-party laboratories. Also, we are planning to request a meeting with the FDA about some of its requests. So, this is currently a very fluid situation."
Once PharmaCyte files its response to the clinical hold letter, the FDA will have 30 days to review the material submitted by PharmaCyte and make its decision whether to lift the hold.